CAR T-Cell Therapy and Secondary Tumour Development – Coincidence or Connection?

Newly developed malignancies of T-cell origin appear to be a rare complication following treatment with authorised CAR T-cell therapies. These cases require individual assessment and ideally molecular testing in order to better understand possible product-specific or patient-specific factors and to use that understanding for risk minimisation. Amid the reception of several reports of such malignancies, a signal procedure was initiated at the European Medicines Agency (EMA) in order to systematically assess the available evidence. The results of this pharmacovigilance evaluation, conducted with the participation of the Paul-Ehrlich-Institut (PEI), are summarised below.